FDA.reportPublic FDA data

Impactor

Primary DI
08056269049665
Brand
Impactor
Company
ADLER ORTHO SPA
Model
Impactor
Catalog number
IZ03520
Device description
PANTHEON ASSEMBLY IMPACTOR STEM D30
Published
2025-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056269049665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056269049665080562690496658056269049665

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
338847291
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08052693621545Tibial ImpactorKP07340KP073402025-11-03
08052693621552Femoral ImpactorKP07350KP073502025-11-03
08053617185211PunchKZ03312KZ033122025-10-08
08053617185228PunchKZ03334KZ033342025-10-08
08053617185235PunchKZ03356KZ033562025-10-08
08056269043618Trial Tibial AugmentKZ00507KZ005072025-11-03
08056269043625Trial Tibial AugmentKZ00527KZ005272025-11-03
08056269044080Trial Tibial AugmentKZ00501KZ005012025-11-03
08056269044097Trial Tibial AugmentKZ00502KZ005022025-11-03
08056269044103Trial Tibial AugmentKZ00503KZ005032025-11-03
08056269044110Trial Tibial AugmentKZ00504KZ005042025-11-03
08056269044127Trial Tibial AugmentKZ00505KZ005052025-11-03
08056269044134Trial Tibial AugmentKZ00506KZ005062025-11-03
08056269044141Trial Tibial AugmentKZ00521KZ005212025-11-03
08056269044158Trial Tibial AugmentKZ00522KZ005222025-11-03
08056269044165Trial Tibial AugmentKZ00523KZ005232025-11-03
08056269044172Trial Tibial AugmentKZ00524KZ005242025-11-03
08056269044189Trial Tibial AugmentKZ00525KZ005252025-11-03
08056269044196Trial Tibial AugmentKZ00526KZ005262025-11-03
08056269044202Trial Tibial AugmentKZ01001KZ010012025-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986489425LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-08-19
08809986489432LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-08-19
M9432002230000Liberty SISpinal Simplicity, LLCLXH2026-08-19
00198506093937ELMED INCORPORATEDELMED INCORPORATEDLXH2026-08-18
00198506094194ELMED INCORPORATEDELMED INCORPORATEDLXH2026-08-18
00810130207534MSIModern Surgical Instruments LLCLXH2026-08-18
00810198920345General InstrumentsTheraMicro, LLCLXH2026-08-18
00810198920352TeKForceTheraMicro, LLCLXH2026-08-18
00810198920376TeKForceTheraMicro, LLCLXH2026-08-18
00850078396396ActivaScrew™ Cannulated COM Single-Use Accessory Kit 3.5/4.0/4.5 mm(1054)Eca Medical InstrumentsLXH2026-08-18
08053782781652Bioplan Instruments KitBRM EXTREMITIES SRLLXH2026-08-18
08057717553635BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553642BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553659BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553666BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553673BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553680BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553697BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553703BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553710BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553727BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553734BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553741BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553758BRM BIOPLAN INSTRUMENTSBRM EXTREMITIES SRLLXH2026-08-18
08800104097980Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.LXH2026-08-18
08800322750834PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322758106PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322758113PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322759523QUASAR Standalone ACIF SystemGS Medical Co., Ltd.LXH2026-08-18
08800322759530QUASAR Standalone ACIF SystemGS Medical Co., Ltd.LXH2026-08-18